Pre-Drawn Syringes of Comirnaty for an Efficient COVID-19 Mass Vaccination: Demonstration of Stability.

Francesca Selmin,Loris Rizzello,Umberto M. Musazzi,Edoardo Scarpa,Patrizia Procacci,Paola Minghetti,Silvia Franzè

doi:10.3390/pharmaceutics13071029

Francesca Selmin, Loris Rizzello + Show 5 more

Open Access

https://doi.org/10.3390/pharmaceutics13071029

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Abstract

Moving towards a real mass vaccination in the context of COVID-19, healthcare professionals are required to face some criticisms due to limited data on the stability of a mRNA-based vaccine (Pfizer-BioNTech COVID-19 Vaccine in the US or Comirnaty in EU) as a dose in a 1 mL-syringe. The stability of the lipid nanoparticles and the encapsulated mRNA was evaluated in a “real-life” scenario. Specifically, we investigated the effects of different storing materials (e.g., syringes vs. glass vials), as well as of temperature and mechanical stress on nucleic acid integrity, number, and particle size distribution of lipid nanoparticles. After 5 h in the syringe, lipid nanoparticles maintained the regular round shape, and the hydrodynamic diameter ranged between 80 and 100 nm with a relatively narrow polydispersity (<0.2). Samples were stable independently of syringe materials and storage conditions. Only strong mechanical stress (e.g., shaking) caused massive aggregation of lipid nanoparticles and mRNA degradation. These proof-of-concept experiments support the hypothesis that vaccine doses can be safely prepared in a dedicated area using an aseptic technique and transferred without affecting their stability.

Highlights

The first vaccine approved in the EU and the US for the prevention of COVID-19, caused by the SARS-CoV-2 virus, is based on mRNA strands packaged in neutrally charged lipid-based nanoparticles (LN)
In an attempt to fill the gaps of background information, we investigated the stability of LN and mRNA of Comirnaty batches stored in either glass vials or 1-mL plastic syringes (made of poly(propylene) or poly(carbonate)), both kept in cold chain (i.e., 2–8 ◦ C), or room temperature (25 ◦ C) over 5 h
Before the need to control the COVID-19 pandemic, LN represented a leading technology for the systemic delivery of siRNA (i.e., Onpattro) [12]. This drug delivery system consists in multicomponent nanoparticles composed of ionizable amino lipids, phospholipids, cholesterol, and a polyethylene glycol-lipid conjugate (PEG-lipid)

Summary

Introduction

The first vaccine approved in the EU and the US for the prevention of COVID-19, caused by the SARS-CoV-2 virus, is based on mRNA strands packaged in neutrally charged lipid-based nanoparticles (LN). This formulation is commercialized as a deep-frozen concentrate for dispersion (Pfizer-BioNTech COVID-19 Vaccine in the US or Comirnaty in EU), which is diluted (upon thawing) just before injecting a 0.3-mL dose intramuscularly. In early 2021, the vaccination campaign had hard tested the operativity of logistic and healthcare systems, as the vaccine concentrate has to be prepared and administered in very short periods since it has to be maintained at 2–8 ◦ C for a maximum of 5 days upon thawing, and diluted and administered within

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